European commission chief defends record, saying EU’s slower approval process was ‘right decision’
The vaccination programme in the UK has enjoyed a head start through compromising on “safety and efficacy” safeguards, the European commission president, Ursula von der Leyen, has claimed.
The former German defence minister, who took command of the EU’s executive branch in 2019, said she had a responsibility to take time to ensure the success of the bloc’s mass vaccination programme.
In the face of heavy criticism, including from her predecessor, Jean-Claude Juncker, Von der Leyen said she was committed to her role and should be judged at the end of her term in 2024.
“Some countries started to vaccinate a little before Europe, it is true,” she said, asked about the UK. “But they resorted to emergency, 24-hour marketing authorisation procedures.
“The commission and the member states agreed not to compromise with the safety and efficacy requirements linked to the authorisation of a vaccine. Time had to be taken to analyse the data, which, even minimised, takes three to four weeks.
“So, yes, Europe left it later, but it was the right decision. I remind you that a vaccine is the injection of an active biological substance into a healthy body. We are talking about mass vaccination here, it is a gigantic responsibility.”
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) gave the go-ahead for the vaccines from Pfizer/BioNTech on 2 December and Oxford/AstraZeneca on 30 December through a temporary, emergency approval of specific batches, an approach also available to EU member states.
The 27 EU governments decided, however, to seek authorisation together through the European Medicines Agency (EMA), which is unable to take the fast-track option. The Pfizer vaccine was approved on 21 December and AstraZeneca received approval last Friday.
Amid criticism at the time of the approval, the MHRA had said it had “rigorously assessed the data in the shortest time possible, without compromising the thoroughness of our review”.
The commission has been criticised over a shortage of vaccine supplies with just 2.84% of the EU’s adult population having received a jab against 14.41% in the UK as of Tuesday.Von der Leyen said the EU was “just starting” and the commission’s strategy was “the right one”, in an interview with Le Monde and other European newspapers.
She has been embroiled in a bitter row with AstraZeneca over a shortage of doses in the first quarter of this year.
The commission has raised suspicions that the shortfall was due to doses being shipped to the UK. Von der Leyen has also demanded that vaccine is produced for EU citizens from plants in Oxford and Staffordshire to make good on the missing deliveries.
She said: “Our contract with AstraZeneca is clear … nothing prevents the company from delivering us doses produced in the United Kingdom, as stipulated in the contract, especially since London does not prohibit it.
“It’s up to AstraZeneca to organise itself to deliver [for] its customers, that’s none of our business. What we want are plausible explanations and a schedule for upcoming deliveries.”
Last week, the EU introduced an export authorisation scheme to force vaccine suppliers to seek approval for moving doses outside of the bloc. The Japanese government has said it fears the move will slow down its vaccination programme by introducing extra paperwork.
Von der Leyen said the new mechanism would reassure the commission that its own doses had not and would not leave the EU.
“From now on, when a laboratory asks for authorisation to export its vaccines, it will also have to say what happened in December 2020 and January,” she said. “We want to know what it produced in its European factories, what was exported, where it was exported and what was stored. Better transparency than rumours.”
On Monday, Juncker, who led the commission between 2014 and 2019, voiced his opposition to the new regulation, adding that the EU programme had been “too slow”.
“We are back in a debate where again the suggestion is being made that nothing should be exported from the European Union to other non-EU countries,” he said. “I am very much opposed to the European Union now giving the impression that we are taking care of ourselves and that the suffering of other people, especially in poorer countries and on poorer continents, does not affect us.”
Von der Leyen did not apologise for the commission’s ill-fated plan to seek to erect a vaccine border on the island of Ireland by triggering a clause in the Brexit withdrawal agreement. The commission was forced into a U-turn on the decision after an outcry by the Irish taoiseach, Micheál Martin, and Boris Johnson, among others.
She said: “I know how sensitive the Irish subject is. But when you take urgent decisions – in this year of crisis, the commission has taken almost 900 – there is always a risk of missing something. I am relieved that we were able to find a solution.”
source: Daniel Boffey